FDA News

FDA approves Opdivo for subtype of metastatic colorectal cancer

The FDA approved nivolumab for the treatment of adult and pediatric patients with microsatellite instability-high or mismatch repair-deficient metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin and irinotecan, according to the drug’s manufacturer.

Nivolumab (Opdivo, Bristol-Myers Squibb), a PD-1 checkpoint inhibitor, received accelerated approval based on data from the multicenter, open-label, single-arm phase 2 CheckMate 142 trial.

That trial evaluated 3 mg/kg nivolumab IV every 2 weeks in 74 patients with microsatellite instability-high or mismatch repair-deficient metastatic colorectal cancer.

Overall, 32% of patients responded to treatment, including 2.7% who experienced a complete response and 30% who experienced a partial response.

Fifty-three patients (72%) had previously received a fluoropyrimidine, oxaliplatin and irinotecan. Researchers reported an overall response rate for these patients of 28% (95% CI, 17-42), which included a complete response rate of 1.9% and partial response rate of 25%. Median duration of response was not reached among these responders (range, 2.8+ months to 22.1+ months).

The most common adverse reactions included fatigue, rash, musculoskeletal pain, pruritus, diarrhea, nausea, asthenia, cough, dyspnea, constipation, decreased appetite, back pain, arthralgia, upper respiratory tract infection and pyrexia.

“As part of our commitment to address hard-to-treat cancers, with today’s approval, Opdivo provides a new treatment option for these patients who have historically faced a poor prognosis,” Chris Boerner, president of U.S. Commercial at Bristol-Myers Squibb, said in a company-issued release. “This approval is one example of how our commitment to translational medicine and investigating predictive biomarkers may help us discover treatment approaches to address different patients’ unique needs.”

The FDA recommended a 240-mg dose of IV nivolumab infused over 60 minutes every 2 weeks until disease progression or unacceptable toxicity.

The FDA approved nivolumab for the treatment of adult and pediatric patients with microsatellite instability-high or mismatch repair-deficient metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin and irinotecan, according to the drug’s manufacturer.

Nivolumab (Opdivo, Bristol-Myers Squibb), a PD-1 checkpoint inhibitor, received accelerated approval based on data from the multicenter, open-label, single-arm phase 2 CheckMate 142 trial.

That trial evaluated 3 mg/kg nivolumab IV every 2 weeks in 74 patients with microsatellite instability-high or mismatch repair-deficient metastatic colorectal cancer.

Overall, 32% of patients responded to treatment, including 2.7% who experienced a complete response and 30% who experienced a partial response.

Fifty-three patients (72%) had previously received a fluoropyrimidine, oxaliplatin and irinotecan. Researchers reported an overall response rate for these patients of 28% (95% CI, 17-42), which included a complete response rate of 1.9% and partial response rate of 25%. Median duration of response was not reached among these responders (range, 2.8+ months to 22.1+ months).

The most common adverse reactions included fatigue, rash, musculoskeletal pain, pruritus, diarrhea, nausea, asthenia, cough, dyspnea, constipation, decreased appetite, back pain, arthralgia, upper respiratory tract infection and pyrexia.

“As part of our commitment to address hard-to-treat cancers, with today’s approval, Opdivo provides a new treatment option for these patients who have historically faced a poor prognosis,” Chris Boerner, president of U.S. Commercial at Bristol-Myers Squibb, said in a company-issued release. “This approval is one example of how our commitment to translational medicine and investigating predictive biomarkers may help us discover treatment approaches to address different patients’ unique needs.”

The FDA recommended a 240-mg dose of IV nivolumab infused over 60 minutes every 2 weeks until disease progression or unacceptable toxicity.

    See more from Immuno-Oncology Resource Center